U.S. patent number 5,025,374 [Application Number 07/130,934] was granted by the patent office on 1991-06-18 for portable system for choosing pre-operative patient test.
This patent grant is currently assigned to ARCH Development Corp.. Invention is credited to Richard E. Pfisterer, Michael Roizen, William E. Turcotte, II.
United States Patent |
5,025,374 |
Roizen , et al. |
June 18, 1991 |
**Please see images for:
( Certificate of Correction ) ** |
Portable system for choosing pre-operative patient test
Abstract
An interactive medical test selector for use by a patient is
about the size of a book and has a screen for displaying questions
to a patient, a limited number of keys by which the patient can
enter answers, and a memory device for storing the patient's
answers. The test selector is battery-powered for portability and
uses a low-power liquid crystal display or the like to display
instructions and medical questions to the patient. Only four keys
are seen or used by the patient for answering the questions: YES,
NO, NOT SURE, and NEXT QUESTION. Additional control keys used by
the medical staff are hidden from the patient. The device is
controlled by a pre-programmed microcomputer on a chip, and a
ROM-based, removable and replaceable control program which not only
collects, but also analyzes the patient's answers and makes
appropriate recommendations based on those answers, and drives a
remote printer or computer terminal.
Inventors: |
Roizen; Michael (Chicago,
IL), Turcotte, II; William E. (Oak Park, IL), Pfisterer;
Richard E. (Arlington Heights, IL) |
Assignee: |
ARCH Development Corp.
(Chicago, IL)
|
Family
ID: |
22447062 |
Appl.
No.: |
07/130,934 |
Filed: |
December 9, 1987 |
Current U.S.
Class: |
600/300;
128/920 |
Current CPC
Class: |
G06F
15/025 (20130101); G09B 7/04 (20130101); G16H
40/63 (20180101); G16H 15/00 (20180101); G16H
10/20 (20180101); Y02A 90/10 (20180101); G16H
40/40 (20180101); G16H 10/60 (20180101); Y10S
128/92 (20130101) |
Current International
Class: |
G09B
7/04 (20060101); G06F 15/02 (20060101); G09B
7/00 (20060101); G06F 19/00 (20060101); G06F
015/42 () |
Field of
Search: |
;364/415,401,413.02,413.01,401 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"Computer-Aided Diagnosis of Dermatologic Disorders"; Computer in
Dermatology, William v. Stuecker..
|
Primary Examiner: Smith; Jerry
Assistant Examiner: Hayes; Gail O.
Attorney, Agent or Firm: Laff, Whitesel, Conte &
Saret
Claims
The invention claimed is:
1. A portable patient-operable pre-operative test selector
especially for use by bed-ridden pre-operative patients, said
selector comprising:
power supply means for accepting a battery, electronic circuitry
connected to derive operating power exclusively from a battery when
installed in said power supply means, said electronic circuitry
including data-storage means for storing a series of pre-operative
questions directed to the determination of which pre-operative
diagnostic tests should be undergone by a patient before surgery,
reflective display means, programmable data-processing means,
control program storage means for storing a program for controlling
said data-processing means, a special-purpose control program
stored therein, said control program being arranged for displaying
said pre-operative questions serially on said display means, means
operable by an unskilled patient to answer "yes" and "no" to each
such question in turn, means for storing such answers, said control
program being further arranged for analyzing said answers and
determining therefrom which pre-operative diagnostic tests are
indicated, and output means for revealing the results of such
determination.
2. A portable test selector for use by an untrained patient to
complete a medical questionnaire, comprising:
read-only memory means for storing (i) a series of preselected
medical questions related to determining which tests among a set of
preselected tests the patient should undergo, and (ii) a decision
table indicating for each of the tests which answers to which
questions should cause that test to be determined as one the
patient should undergo;
scratchpad memory means for storing data; means for reading said
data from said scratchpad memory means
display means for displaying information to the patient;
interrogation means for causing the medical questions stored in
said read-only memory means to be displayed to the patient by the
display means;
manual input means for enabling the patient to indicate an answer
to a displayed question; and
tabulating means for enabling the patient to indicate an answer to
a displayed question; and
tabulating means for causing the corresponding answer indicated by
the patient via the manual input means to be stored as data in the
scratchpad memory means;
wherein the read-only memory means is easily removable from the
test selector and replaceable to enable updating of the medical
questions and decision table.
3. A portable test selector for use by an untrained patient to
complete a medical questionnaire, comprising:
read-only memory means for storing (i) a series of preselected
medical questions related to determining which test among a set of
preselected test the patient should undergo, and (ii) a decision
table indicating for each of the tests which answers to which
questions should cause that test to be determined as one the
patient should undergo;
scratchpad memory means for storing data; means for reading said
data from said scratchpad memory means
display means for displaying information to the patient;
interrogation means for causing the medical questions stored in
said read-only memory means to be displayed to the patient by the
display means;
manual input means for enabling the patient to indicate an answer
to a displayed question; and
tabulating means for causing the corresponding answer indicated by
the patient via the manual input means to be stored as data in the
scratchpad memory means;
wherein the medical questions are those requiring an answer of YES
or NO or NOT SURE, and the manual input means enables the patient
to indicate YES, NO, or NOT SURE as the answer.
4. A portable test selector for use by an untrained patient to
complete a medical questionnaire, comprising:
read-only memory means for storing (i) a series of preselected
medical questions related to determining which tests among a set of
preselected tests the patient should undergo, and (ii) a decision
table indicating for each of the test which answers to which
questions should cause that test to be determined as one the
patient should undergo;
scratchpad memory means for storing data; means for reading said
data from said scratchpad memory means
display means for displaying information to the patient;
interrogation means for causing the medical questions stored in
said read-only memory means to be displayed to the patient by the
display means;
manual input means for enabling the patient to indicate an answer
to a displayed question;
tabulating means for causing the corresponding answer indicated by
the patient via the manual input means to be stored as data in the
scratchpad memory means;
and reporting means responsive to the answers stored in the
scratchpad memory and the decision table stored in the read-only
memory means for determining for each test if the patient's answers
to one or more questions should cause that test to be determined as
one the patient should undergo.
5. The device of claim 4 and further including printer interface
means to which a data input line to a printer can be coupled; and
report generator means, responsive to the reporting means, for
sending as output to the printer interface a list of only the tests
which the reporting means has determined are ones the patient
should undergo.
6. A portable test selector for use by an untrained patient to
complete a medical questionnaire, comprising:
read-only memory means for storing (i) a series of preselected
medical questions related to determining which tests among a set of
preselected tests the patient should undergo, and (ii) a decision
table indicating for each of the tests which answers to which
questions should cause that test to be determined as one the
patient should undergo;
scratchpad memory means for storing data; means for reading said
data from said scratchpad memory means
display means for displaying information to the patient;
interrogation means for causing the medical questions stored in
said read-only memory means to be displayed to the patient by the
display means;
manual input means for enabling the patient to indicate an answer
to a displayed question;
tabulating means for causing the corresponding answer indicated by
the patient via the manual input means to be stored as data in the
scratchpad memory means;
and questionnaire printout preparation means responsive to the
medical questions stored in the read-only memory means and the
answers stored in the scratchpad memory means for determining, for
each possible patient answer, to which questions the patient gave
that answer.
7. The device of claim 6 and further including printer interface
means to which the data input line to a printer can be coupled; and
list generator means, responsive to the questionnaire printout
preparation means, for sending as output to the printer interface a
list of the questions and the patient's answers.
8. The device of claim 7 wherein the list generator means is
arranged for sending the questions and the patient's answers to the
printer interface with each question sorted according to the answer
given to that question by the patient.
Description
NOTICE REGARDING COPYRIGHTS
A portion of the disclosure of this patent document contains
material which is subject to copyright protection. The copyright
owner has no objection to the facsimile reproduction by anyone of
the patent disclosure, as it appears in the Patent and Trademark
Office patent files or records, but otherwise reserves all
copyright rights whatsoever.
This invention relates to a medical test selecting device, and more
particularly to a portable computerized device which administers a
questionnaire to a patient, especially a surgical patient, even if
the patient is bed-ridden, and is capable of printing out a full
report including advice to a physician as to what pre-operative or
other medical tests are indicated for that patient.
BACKGROUND OF THE INVENTION
It has been estimated that of the approximately $30 billion spent
each year in the United States for medical tests, as much as 60% of
that amount ($18 billion) is wasted on unnecessary tests; i.e.,
those which, for a given patient, would not be needed if the
physician had the benefit of a reliable medical history. See, for
example, Are We Hooked on Tests, U.S. News & World Report, Nov.
23, 1987, pp. 60-65, 68-70, 72.
This problem of unnecessary testing is particularly acute in cases
where a patient is about to undergo surgery and, in order to
determine the proper anesthesia, the patient's general medical
history is taken.
This medical history strongly influences which diagnostic tests the
medical staff chooses to perform before surgery. For example, if
the patient discloses that he or she has any pain or discomfort
upon urination, or has noticed any blood in the urine, then a
urinalysis (a chemical analysis of the urine) ought to be
performed. But if those symptoms are not present, it is considered
medically unnecessary to administer a urinalysis, absent some other
medical indication for the test.
Under current medical practice, it requires about seventy-five or
more questions to determine which, if any, of the various available
pre-operative tests (urinalysis, chest x-rays, EKG, etc.) might
have to be performed before determining what anesthesia ought to be
used during surgery. If the physician is not sure that all these
questions were properly asked, or has doubts about the care with
which the patient's answers have been recorded, he or she is likely
to include in the battery of pre-operative tests many that could
have been excluded based on an accurate patient history.
To save the time of physicians, questionnaires have been devised
that can be administered by a nurse or other trained medical
worker, or even directly filled in by the patient. But the time of
a trained medical worker is also too valuable to spend on such
tasks, since that makes the individual unavailable to perform
other, more pressing, medical tasks which require such
training.
If the patient completes the questionnaire alone, he or she may
overlook or ignore some of the questions. Also, if the patient
usually reads in a foreign language or has vision problems, he or
she may have trouble completing the questionnaire alone.
Even if a questionnaire is fully and properly filled out, tallying
of the patient's answers to determine which tests are needed is a
time-consuming and tedious task, in the course of which medical
workers sometimes inadvertently introduce errors.
Because of these problems, all too often a reliable medical history
of this type is not taken prior to surgery, in which case the
patient may have to undergo a comprehensive battery of
pre-operative tests, many of them unneeded. These unnecessary tests
are expensive for the patient and a burden on an already overworked
medical system. In addition, the more tests are done the greater is
the risk of false positives and iatrogenic harm from pursuit of
false positives. Therefore, there is a great need to "automate" the
reliable taking and tabulating of pre-operative test
questionnaires.
THE PRIOR ART
The prior art has proposed the use of computers or computer
terminals to automate the taking of general-purpose medical
histories. For example, in U.S. Pat. No. 3,566,370 of Worthington
et al. a computer terminal which is connected by telephone lines to
a mainframe computer displays questions on a CRT screen which are
to be answered by the patient sitting at a full alphanumeric
keyboard. After the patient answers the questions, the computer
stores, formats and prints out the patient's medical history. The
Worthington patent also suggests that the questions presented to
the patient for the purpose of taking his medical history can be in
foreign languages when necessary. U.S. Pat. No. 4,130,881 of
Haessler et al. is similar to Worthington in many respects.
Published Japanese Patent Application No. 59-231676 is similar to
the above-mentioned U.S. patents in its use of a computer console
and full alphanumeric keyboard, except that in addition the
computer there is programmed to develop recommendations. The
recommendations are intended for the guidance of Japanese
pharmacists, not medically trained physicians, in prescribing oral
medications according to Chinese traditional folk medicine
criteria. To date no computerized system has been developed which
is specifically programmed to administer the particular sequence of
questions which is considered appropriate for pre-operative test
selection according to accepted western scientific medical
criteria.
General-purpose computing machines of the type employed in the
above prior art patents are much too expensive, bulky, and
complicated for the task of automating the pre-operative test
selection process. Moreover, the great majority of patients are not
"computer literate" and find such equipment difficult to use even
when they are feeling well. A patient who is about to go into
surgery in the very near future is particularly likely to find a
large-scale general-purpose computer system confusing and
threatening. The problem is exacerbated by the fact that these
computers require the patient to compose an answer on a keyboard
containing the full range of alphanumeric characters and other
keys.
The prior art has recognized the need in certain contexts for a
simplified special-purpose data-processing device which offers the
non-computer-literate person a simple choice between "yes" and "no"
answers, as in published French Patent Application No. 77 17048.
But the computer in that application is programmed to recommend a
skin cosmetic regime rather than a medical treatment procedure.
A pre-operative patient is sometimes in such poor condition that it
would be physically difficult to get out of bed and sit at the
keyboard of large-scale computer system. Ideally, therefore, an
automated pre-operative test recommendation device would be small
enough to be portable. Here again, the prior art does have examples
of portable special-purpose computers, but these too have not been
adapted for use in a pre-operative test selection environment. The
portable computer in U.S. Pat. No. 4,686,624 of Blum et al., for
example, is dedicated to controlling the dietary habits of
diabetics.
BRIEF SUMMARY OF THE INVENTION
Accordingly, one general object of the invention is to provide a
automatic device for taking patient histories which is especially
adapted for the selection of medical and/or pre-operative tests,
and can be easily used even by bed-ridden patients. A more
particular object is to provide a small, battery-powered, portable
dedicated computer that automatically displays questions and
enables a non-computer-literate patient to answer by means of only
a few keys. A further object is to provide such a device that
automatically analyzes the patient's answers to determine which
tests appear to be necessary, and provides a printed report. Yet
another object is to provide a device which is medically reliable,
but is nevertheless relatively inexpensive. It is also desirable to
provide a device of this type which can be easily be field-modified
to update the questions at intervals to keep up with the progress
of medical knowledge. Such a device should also be capable of
communicating with either the patient or the doctor in a foreign
language when necessary.
The invention provides a hand-held, battery-powered medical and/or
pre-operative test selector for use by a patient which has means
for displaying questions to a patient, a limited number of keys by
which the patient can enter answers, and a memory device for
storing the patient's answers. Alternatively, an audio jack enables
the patient to listen to the questions with earphones. The device
preferably uses a low-power display such as a liquid crystal or the
like. In a preferred embodiment, no more than four keys are used by
the patient: YES, NO, NOT SURE, and GO TO NEXT QUESTION (hereafter
"NEXT QUESTION"). Additional control keys may be provided for use
by the medical staff, but are hidden from the patient. The device
is controlled by a pre-programmed microcomputer on a chip which
stores in a memory the text of user instructions, medical or
pre-operative questions, and words to be used in printed reports.
The microcomputer is programmed to tally the patient's answers and,
on the basis of that information, to indicate which tests are
advisable. The test selector can be provided with additional
prestored text so the user has the option of displaying questions
in more than one language, or being asked the questions in an audio
mode. The questions and the software for recommending pre-operative
tests are stored in a readily removable and replaceable integrated
circuit chip to facilitate updating of the questions and/or the
test selection procedure at intervals, as medical knowledge
advances.
BRIEF DESCRIPTION OF THE DRAWINGS
These mentioned and other features of the invention will become
more apparent, and the operation of the invention will be best
understood, by reference to the following detailed description of
preferred embodiments of the invention, when taken in conjunction
with the accompanying drawings, in which:
FIG. 1 is perspective view of an exemplary pre-operative test
selector according to the invention;
FIG. 2 is a diagram showing the test selector connected to a
printer to produce printed output;
FIGS. 3A-3F are views of the display and control keys of the test
selector when it is in various modes of operation;
FIG. 4 is a diagram showing the test selector coupled to a computer
terminal;
FIG. 5 is a functional block diagram of the main hardware
components used in the test selector, and their
interconnection;
FIG. 6 is a diagrammatic representation of a program used to
control the test selector, showing a functional representation of
the systems software;
FIG. 7 is a flowchart of the Main Menu program shown in FIG. 6;
FIGS. 8A, 8B, and 8C are partial flowcharts showing how portions of
the program of FIG. 7 can be modified to give the option of a
second language for the display and printed reports of the test
selector;
FIG. 9 is a flowchart of a first embodiment of the "Ask Questions,
Store Answers" subroutine of FIG. 7;
FIG. 10 is a flowchart of the "Print Docreport" subroutine of FIG.
7, which prints a report for a doctor;
FIG. 11 is a flowchart of the "PrintQ&A" subroutine of FIG. 7,
which prints a list of questions presented and the patient's
answers, sorted by answer and question type;
FIG. 12; is a flowchart of the "SORT AND PRINT QUESTIONS AND
ANSWERS" subroutine used in the PrintQ&A subroutine of FIG.
11.
FIGS. 13A-13F show nodes representing questions to be asked and
various arrangements of program paths linking the questions;
and
FIG. 14 is a flowchart of a second embodiment of the "Ask
Questions, Store Answers" subroutine of FIG. 7.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
1. General Appearance and Functions
A portable interactive test selector 20 embodying the invention is
shown in FIG. 1, in the Question & Answer (Q&A) mode used
by a patient. Preferably it is battery-powered and about the size
of a book or calculator so that a patient can operate it on his or
her lap, or at a desk or table. Built in to an operating panel 20a
are a text display 22 and a patient keypad 26.
The operating panel also has a control keypad 36 which is kept
inconspicuous or hidden from the patient. For example, the control
keypad may be concealed by a translucent plastic sheet, but have
labeled keys that can be illuminated to make the key labels visible
from behind the translucent sheet. Or the control keypad can be
hidden from the patient behind a sliding panel or the like.
Yet another alternative for the control keypad 36 is to provide a
row of small, unlabeled, switch buttons 39 just below text display
22. When these switches 39, which can be membrane switches or
nonmoving capacitance-sensitive switches, are activated by a
medical staffer, numerical labels for them (not shown) can be made
to appear in the bottom row of display 22.
Test selector 20 also has a back panel 20b, on which are arrayed an
ON/OFF switch 21a, a control button 21b, a socket 21c for a battery
recharger, a recharging lamp 21d, a printer jack 21e, and an audio
output jack.
A side panel 38 of the test selector has a recess 38a for receiving
a read-only memory (ROM) cartridge 38b for updating a control
program and test information.
A series of prestored YES/NO questions 24 for the patient appear
one at a time on text display 22, to each of which the patient
responds in turn by pressing an appropriate answer key on the
patient keypad 26. Alternatively, the coded sounds for these
questions can be stored in a speech ROM and converted from digital
to analog to give an audio reading of the questions to the patient
via a speaker or headphones using audio jack 21f.
Keypad 26 has only a very limited number of keys, such as four keys
28-34 for the choices YES, NO, NOT SURE (N.S.), and NEXT QUESTION.
Pressing an answer key 28, 30, 32 causes the answer chosen to be
echoed in the display as input echo 25. For example, in FIG. 1, the
patient has pressed the NOT SURE key, causing the text "NOT SURE"
to appear in the display as input echo 25.
However, the answer echoed on the display at 25 is not considered
the patient's final answer until the patient presses a NEXT
QUESTION key 34, which acts like the "Enter" or "Return Key" on a
microcomputer. Until Next Answer key 34 is pressed, the patient can
change the echoed answer by pressing one of the other answer keys,
then press the "NEXT QUESTION" key to adopt it as his or her final
answer.
As will be seen below, a patient is instructed that if he or she
has answered a question by pressing one of answer keys 28, 30, 32
and "NEXT QUESTION" key 34 and afterwards wants to go back to that
question, the test selector should be returned to the medical staff
for resetting. Then a staff person uses control key 21b to
illuminate control keypad 36, and presses backup key 37 to back up
the display to the prior question. This enables the patient to
enter a revised answer by one of keys 28, 30, and 32, followed by
NEXT QUESTION key 34.
It has been found that this very limited set of keys makes it easy
for even the typical non-computer-literate patient to use the test
selector with little or no instruction. To the typical patient,
these keys are as easy as, or easier than, as those found in
elevator controls, simple household appliances, etc.
As shown in FIG. 2, when the patient has read and answered a full
set of questions, test selector 20 can be attached by a printer
cable 40 to a standard ASCII printer 42 to print out reports based
on the patient's answers. A plug (not shown) on printer cable 40 is
inserted into printer jack 21e.
Preferably, the printer has an input for serial data complying with
the popular interface standard RS-232C of the Electronic Industry
Association, and the handshaking between the test selector and
printer is software controlled. Then cable 40 will only need three
lines a line for data and control signals transmitted by the test
selector and received by the printer, a line for data and control
signals transmitted by the printer and received by the test
selector, and a ground or common connection.
In such a case, printer jack 21e and its matching plug (not shown)
can be simple miniature three wire stereo jacks, such as are found
on audio equipment for connecting stereo headphones. Such jack and
plug sets are compact, lightweight, and snap together and apart
easily, making them much easier to use than standard 25 or 9 pin
serial connectors for microcomputer equipment.
2. General Method of Operation
In operation, the medical staff person administering the test
(hereafter "staffer") controls the mode of the test selector by
selecting from choices presented by display 22, as shown in FIGS.
3A-3F. When the test selector is first turned on, control keypad 36
is lit or otherwise made usable as shown in FIG. 3A, and display 22
prompts "PLEASE ENTER ACCESS CODE". In response, the staffer must
enter a four digit secret access code (password) via control keypad
36. The four integers keyed in by the staffer are echoed on display
22 merely as X's to keep the access code secret.
If the staffer's access code is correct, FIG. 3B, the display
changes to an opening menu offering the following choices:
______________________________________ 1) ASK QUESTIONS 5) RUN
DIAGNOSTICS 2) PRINT RESULTS 6) COMMUNICATIONS 3) PRINT RESPONSES
4) SET DATE/TIME ______________________________________
The control keypad remains lit or otherwise usable for the
staffer's choice, which appears as input echo 25.
Suppose, as in FIG. 3B, that the staffer presses 1 on the control
keypad for the selector to administer a questionnaire to a patient.
Then as shown in FIG. 3C, the illumination of the control keypad is
turned off, concealing it, and the display shows an introductory
message and an initial prompt for the patient to confirm that he or
she has read the message:
PLEASE ANSWER THE FOLLOWING QUESTIONS. TO PROCEED, PRESS YOUR
ANSWER AND THEN THE NEXT QUESTION BUTTON. ARE YOU READY TO
CONTINUE?
Then the display shows a brief series of introductory screens about
the way the patient should operate the test selector. This
introduction advances by one screen each time the patient presses
an answer key followed by the NEXT QUESTION key to indicate that he
or she is ready for the next instruction.
With the introductory screens completed, the first medical history
question appears in display 22, as shown in FIG. 3D.
When the patient has read and responded to each of the prestored
questions, a message appears in display 22 asking that the test
selector be returned to the staffer for analysis. The next time any
key is pressed, the test selector illuminates the control keys and
displays a prompt for the staffer to enter his or her access code.
If the staffer's access code is accepted, a command menu similar to
that of FIG. 3B appears from which the staffer can choose the next
mode of operation.
Usually the staffer's choice will be to press control key 2 to
print a report for the patient's physician (see Appendix I) or
control key 3 to print a "hard copy" of the patient's questions and
answers for signature by the patient (see Appendix II). The printed
copy for signature can include various notices and disclosures to
the patient, and follow-up questions with blanks where the patient
can fill in a response. For example, if the patient has answered
"YES", he or she has allergies, a follow-up question will be
printed at the top of the hard copy for completion:
WHAT ARE YOU ALLERGIC TO?
3. Connection to Work Station
In addition to being printed out, the machine-readable reports and
the patient's responses can be transmitted as shown in FIG. 4 to
whatever computerized medical record-keeping or management system
is being used by the patient's physician or hospital. For example,
the physician or hospital may use a computerized workstation 50
having a microcomputer or terminal 52 with keyboard 54, a printer
42, and an RS-232C serial port 57 for data communications. The
microcomputer or terminal 52 may be coupled to a larger system,
such as a hospital or laboratory mainframe computer, by a network
connection 56.
Test selector 20 can be directly coupled by a serial cable 40 to an
RS-232C interface of the workstation for uploading of the question
and answer data obtained from the patient, or downloading of data
such as the patient's name, as entered on keyboard 54 of the
workstation's computer 52, for use in the reports printed under
direction of test selector 20.
If the test selector is being used in a location remote from the
work station, each can be coupled for communication to a common
phone line (external or intercom) by respective modems. In a
preferred embodiment of the invention, to eliminate the need for
actual mechanical coupling of electrical connectors the workstation
is provided with an infrared transceiver 68 which uses infrared
signals 72 to transfer data to and from a similar infrared
transceiver 70 that is coupled to test selector 20.
4. Circuit Construction
The test selector of the present invention can be conveniently and
inexpensively realized by means of the microprocessor-based circuit
120 shown in the functional block diagram of FIG. 5. A
microprocessor 122 receives its operating voltage from a power
supply 124 that regulates the power from a rechargeable batter 126.
The power supply is controlled by the ON/OFF switch 21a of FIG. 1
and can receive external electrical power for recharging battery
126 via AC/DC recharger socket 21c. Charging lamp 21d is lit
whenever power supply 124 is recharging battery 126 from the
external power. When battery 126 is fully charged, the charging
automatically stops and charging lamp 21d goes out.
An operator keyboard 127 and a patient keyboard 128 are each
coupled to ports on the microprocessor to provide digital input
data from the medical staff and patients. Control switch 21b is
connected to an input terminal of the microprocessor. When the
patient is answering questions, the operator keyboard 127 is not
illuminated to conceal it. However, if a staffer presses control
switch 21b, microcomputer 122 relights control keypad 127 so the
staffer can use backup key 37 of FIG. 1 to return the display to a
previous question for the patient.
The microprocessor has a multiplexed address and data bus 134 by
which it is able to send data bytes to a display driver 136,
read-only memories ROM 1 and ROM 2, and a scratchpad random access
memory RAM 142. Display driver 136 delivers ASCII text data to a
display 137, which, for example, can be a supertwist liquid crystal
display (LCD) capable of displaying four lines of forty characters.
Preferably the character set includes not only the usual 128 ASCII
characters, but an additional 128 symbols which include the
international letters and symbols needed for foreign alphabets.
ROM 138 serves as a primary read-only memory in which can be stored
the operating program for the microcomputer and the text used for
the test selector's questions, answers, and reports. ROM 140 is
optional, and when present serves as a secondary read-only memory
which stores an alternate language version of the text data for the
test selector's questions, answers, and reports. Thus, ROM 2 makes
it possible for the questions, answers, and/or reports to be
displayed by display 137 and/or printed out in a second
language.
It is an important feature of the invention that ROMS 1 and 2 can
be easily replaced by an untrained medical staffer. For example,
they can be combined in ROM cartridge 38b for easy removal and
insertion into recess 38a of side 38 of the test selector. This
enables the control program, the questions asked, and the
recommendations to the doctor to be easily updated to the latest
version.
Suppose ROM 1 holds English text because the physician's office
primarily uses English, but the patient primarily reads Spanish. If
ROM 2 stores a Spanish version of the text of the questions,
answers, and reports, by a software selection portions of ROM 2 can
be addressed in place of those in ROM 1 to display the questions
and answers in Spanish. The questions and answers, and follow-up
questions can also be printed in Spanish. However, the staff can
revert back to ROM 1 for an English version of the questions and
answers and an English report of results to the physician.
A clock/calendar chip 144 is provided so that the time and date 23
can appear in the display (FIG. 3A) and be stamped on the printed
reports and questionnaires. Moreover, since medical information and
practice are constantly being updated, if desired the time and date
information can be used to automatically check an expiration or
date stored with the medical data in ROM 1. If the data in ROM 1
becomes older than this date, a notice can be included in the
display or in the printouts, or the test selector can be prevented
from functioning until the ROM is updated.
If desired, an audio driver 146 can be coupled to an output port of
microprocessor 122, to enable the microprocessor to send tones,
sounds, or voice information to users via an external speaker 147
or headphones 147a via the audio jack 21f of FIG. 1.
To convert the microprocessor's parallel data into serial signals,
microprocessor 122 includes an internal universal asynchronous
receiver/transmitter (UART) 148 which is coupled to an output
RS-232C-compatible serial connector 21e. To print connector
21e.
In the embodiment of the example, microprocessor 122 can be an
eight-bit Hitachi Ltd. HD6303 chip of low power CMOS construction.
Mode 3 of this single chip processor configures it to run as a
microprocessor with a sixteen-bit (64K) address bus and a eight-bit
data bus. An external crystal is used to maintain a clock frequency
of about 4 MHz. The relatively large 64 kilobyte (KB) external
address space easily enables external RAM 142 to be a two-KB
scratchpad memory, and the external ROM 138 to be provided with
about 8 KB of program code and 24 KB of text and related data for
the questions, answers, and reports. Moreover, there is still
plenty of room for second language ROM 140.
The program for this microprocessor, was written in Microtext
Assembler language, which is compatible with the assembler language
produced by Motorola. A source code listing for a first embodiment
is attached to this application as Appendix III, and a source code
listing for a second embodiment of the invention is attached as
Appendix IV.
5. Software Construction
a. Generally
The various operations carried out by the microprocessor-based
circuit of FIG. 5 are represented in the functional block diagram
of FIG. 6. The main operating routine displays the Main Menu 80
(see FIG. 3B), prompting the medical staff to choose one of the
main subroutines by entering a menu number via the control
keypad.
The main subroutines are those for Asking Questions and Recording
Answers 82, Printing a Report for the Doctor, Printing the
Patient's Questions and Answers for Signature, Setting the Time and
Date 88, and various Utilities 90. If optional language ROM 2 is
installed, whenever 82, 84, or 86 is selected, the language that
should be used is next determined by a corresponding language
option routine 83, 85 or 87.
An important feature of the invention is that reports and
questionnaires can be automatically date stamped, and the medical
information in ROM 1 can be automatically checked to see if it
should be renewed. However, this requires that subroutine 88 be
provided to enable the clock/calendar chip 144 to be properly set
by the medical staff or at the factory prior to shipping.
Subroutine 90 includes various utilities, such as dedicated
communication programs for uploading or downloading data to
workstation 50 of FIG. 4 or running diagnostics to check circuit
and data integrity.
Supporting the above-mentioned high-level subroutines ar various
lower-level input/output routines that interface with the hardware.
Display driver 92 manages the data flow to LCD display 93. The
subroutines 94 and 96 respectively get staffer and patient input
from the control and patient keypads. Clock/calendar driver 98
makes clock/calendar 99 software accessible, and drivers 100 for
the serial printer 102 and serial communications control
input/output to serial port 101 or an external modem 103.
b. Main Menu Routine
As shown in FIG. 7, Main Menu routine is the first routine called
when power is provided to the microprocessor system. At Step 200
the system is initialized and diagnostics run, after which at Step
201 a flag called VALIDDATA is cleared. The message "ENTER ACCESS
CODE" shown on display 22 by STEP 202, and the control pad read for
the secret four-integer access code entered by the medical staffer.
If Step 203 determines that the four integers read are not a valid
access code, Step 204 puts "INVALID PASSWORD" on display 22, and at
Step 205 this error message is left in place until there a further
input is read from the control keypad at Step 202.
When Step 203 finds that a valid access code has been input, at
Step 206 the Main Menu of FIG. 3B is displayed, and the medical
staffer asked to enter a command integer 1-6. If the command
integer is 1, Step 207 calls a subroutine ASK QUESTIONS, STORE
ANSWERS at Step 208. This subroutine administers the prestored
medical questionnaire to the patient and stores his or her answers.
As subroutine 208 is completed, it sets the VALIDDATA flag (step
not shown). Next at Step 209 "QUESTIONS COMPLETED, RETURN UNIT" is
displayed to the patient. Step 210 keeps this message on the
display until the next keyboard input.
When the patient returns the test selector to the medical staffer,
and a key of the control pad is touched, the wait at Step 210 ends
and "Q&A COMPLETED, ENTER ACCESS CODE" is displayed to the
medical staffer. When Step 213 find that the staffer again enters a
valid four-integer access code, a jump is made at Step 214 back to
the main menu display of Step 206. But if the code is wrong, a jump
is made back to Step 210 to request the access code again.
Suppose that a set of valid question and answer data has been
taken, a proper access code entered by the medical staffer at Step
212, and a jump made back to the Main Menu of Step 206. The medical
staffer will probably now select a printout option, either command
integer 2 (prints a report for the doctor) or 3 (prints the
questionnaire with follow-up questions, etc.). If command integer 2
is selected, Step 207 will be a "NO" and Step 215 will be a "YES".
Step 216 then checks to see if the VALIDDATA flag is set to avoid
printing partial, meaningless, or corrupted data. If VALIDDATA flag
is set, at Step 217 a subroutine PRINT DOCREPORT prints a report
with test recommendations for the doctor. An example of such a
report appears as Appendix I.
If at Step 216 the VALIDDATA flag is found not to be sent, a jump
is made to Step 218, which prints an error message "INVALID DATA",
after which Step 219 waits for the next keypad input and then
causes a jump back to the Main Menu 206.
When the command integer selected by the staffer at Step 206 is a
3, Steps 207 and 215 both "NO", and Step 220 is "YES". This causes
Step 221 to check if the VALIDDATA is set: if it is, the PRINT
Q&A RESPONSES subroutine of Step 222 prints the questions and
the patient's answers, and then jumps back to the main menu. But if
Step 221 finds that the VALIDDATA flag is not set, a jump is made
to print the error message of Step 218, pause until the next key
input at step 219, and jump back to the main menu of Step 206.
Of course, the staffer may select a housekeeping function at Step
206, such as command integer 4, which passes as a "NO" through
steps 207, 215, and 220, but is a "YES" for Step 223. This causes
the subroutine of Step 224 to get a new time or date from the
control keypad, i.e., let the medical staffer set the
clock/calendar.
Or the staffer may select command integer 6, which at Step 227
causes a communications subroutine 228 to run so that data or
patient information, such as medications, birthdate, or responses
to questions, can be transferred to or from the test selector to a
work station or the like.
If the command integer is other than 1-6, the program will pass to
Step 229, which puts "INVALID NUMBER, PLEASE TRY AGAIN" on the
display. After a wait at Step for 230 for keypad input, the routine
jumps back to the Main Menu. Note that, barring a crash of a
subroutine, the Main Menu routine runs in an endless loop.
c. Accommodating A Second Language
If the second language ROM 2 of FIG. 5 is present, there must be
additional steps added to the Main Menu routine to allow the option
of using the second language. For example, the partial flowchart of
FIG. 8A adds such steps in FIG. 7 between steps 207 and 208. If in
FIG. 7 command integer 1 is selected, Step 207 of FIG. 8A is "YES",
transferring control to Step 207a, which checks to see if an
additional language ROM 2 is present. If it isn't, Step 207a is a
"NO" and the normal path to the subroutine of Step 208 is
followed.
But if the second language ROM 2 is present, a "YES" at Step 207a
causes Step 207b to put "USE SECOND LANGUAGE? " on display 22. The
staffer's response is either "YES", "NO", or "NOT SURE" read from
the Patient Keypad, which is stored as 2NDLANG. If 2NDLANG is a
"YES" at Step 207c, a LANGUAGE flag is set at Step 207d, and the
program moves on to subroutine 208. Subroutine 208 can then check
to see if the LANGUAGE flag is set, and if it is, get text for
display 22 from locations in ROM 2 rather than in ROM1, causing the
second language to be displayed to the patient.
Even if the second language ROM 2 is present, the staffer may have
decided to use the primary language, in which case 2NDLANG will be
a "NO" or NOT SURE at Step 207c, and the LANGUAGE flag will be
cleared at Step 207e before a branch to subroutine 208.
In a similar manner, as shown in FIG. 8B, second language steps can
be inserted between Steps 215 and 216 of FIG. 7 to affect the
language in which the Doctor's Report is printed. If Step 215a
finds that ROM 2 is not present, the usual transfer to Step 216 to
check the VALIDDATA flag is made. But if ROM 2 is present, Step
215b puts the question "USE SECOND LANGUAGE?" on the display. If
the staffer enters "YES" on the patient keyboard, this is detected
by STEP 215c, and the LANGUAGE flag is set at Step 215d. Subroutine
217 of FIG. 7 can check to see if the LANGUAGE flag is set, and if
it is, get text for printing from locations in ROM 2 rather than in
ROM 1, causing the second language to be used for the Doctor's
Report.
If the staffer instead enters "NO" or "NOT SURE", Step 215e clears
the LANGUAGE flag and jumps to Step 216.
The additional steps of FIG. 368C work in a manner similar to those
of FIG. 8B, except that they are inserted between Steps 220 and 221
of FIG. 7 and it is the PRINT Q&A Responses subroutine 222 that
must use the 2d language text in ROM 2 if the LANGUAGE is set.
d. Ask Questions and Store Answers
Next, FIG. 9 shows in some detail how the ASK QUESTIONS, STORE
ANSWERS subroutine 208 of FIG. 7 is effected. Beginning at Step
300, the address of the array "HOWTOUSE" is loaded and saved for
reference. This array has the instruction screens for the patient
explaining how the test selector keys are used to answer questions.
The data for the instruction screens are saved as character strings
in memory, each starting at a known location. The last screen is a
dummy which only contains one byte of data, hexadecimal 0 (Oh).
Thus, Step 302 tests the first byte of Instruction N for Oh. The
Instruction screens have some other hexadecimal number in the first
byte, so Step 303 causes Instruction screen N to be displayed and N
incremented. Then Step 304 causes a pause until the next answer
keypad input, after which there is a jump to Step 302 to begin to
check the first byte the next Instruction Screen.
Finally, the first byte in the last (dummy) screen is detected,
indicating that all the Instruction Screens have appeared to the
patient on display 22. A jump is made to Step 305 where the sex or
WOMANFLAG is set as a default and the VALIDDATA flag cleared as a
default.
The address of the QUESTIONS array is found and stored at Step 306,
and the index N is restarted at N=1.
Before proceeding further, it is necessary to explain the format
and contents related to each question stored in the read-only
memory ROM 1. Each question for the patient is stored in memory as
part of a Question Structure of the form:
<Question Number><Assoc Flag><Question
Class><Text String>
This formatting can be understood as follows:
<Question Number> is the number of the question, except in
the case of the last or dummy question, which is given a Question
Number of 0h to indicate the end of the questions.
<Assoc Flag> is a code in which "0" indicates a default or
ordinary question A "1" indicates that the question has an
associated text string, such as a follow-up question or a comment.
A "2" indicates a question that should only be asked of
females.
<Question Class> is a sorting code for identifying the type
of question, as follows: 1=Lab Test Question, 2=Anesthesia
Question, 3=General Heath Question.
<Text String> is a string of ASCII characters making up the
text of the question, including any characters reserved to
represent carriage returns and line feeds, with the last byte being
a Oh to indicate that the string has ended.
If <Assoc Flag> is 1, the Question Structure further includes
from one to three more character strings, identified as:
<Follow-up Question String>
<YES Comment String>
<NO Comment String>
The follow-up question is necessary when the patient indicates some
complication. For example, if the patient says he or she had an EKG
test in the last two months, the follow-up asks where, providing a
blank line to be filled in the printout of Questions and
Answers.
The YES or NO comment strings put short statements in the report to
the doctor of points to be noticed because of a YES or NO reply.
For example, "Patient has loose teeth". "Patient may not have had
an EKG in the last 2 months."
Returning to the ASK QUESTION, STORE ANSWERS subroutine of FIG. 9,
at Step 307 the first byte of the Nth Question Structure in the
Array is examined to see if it is 0. If it is, we must have reached
the dummy question that indicates the end of the questions. A
branch is made to Step 308, which sets the VALIDDATA flag and at
Step 309 a Return From Subroutine is made.
However, at first N=1 and the answer at Step 307 is "NO". Although
Step 310 checks to see if the WOMANFLAG is set, which initially it
always is because of Step 305. Later, Question 54 will ask if the
patient is a woman, clearing the WOMANFLAG if the patient answers
that he is a man. Questions that follow Question 54 can then be
omitted, depending on the patient's sex.
Therefore, at first the program will always jump to Step 312, which
puts the text of the Nth question on the display and waits for an
answer at the patient's keyboard. Assuming there is no backup to an
earlier question, and the gender question (N=54) has not been
reached, Step 317 saves the patient's YES, NO or NOT SURE answer as
distinguishable binary codes in the Nth entry of an answer array
ANSARRAY1. At Step 322 the two's complement of the answer code is
saved in a second answer array ANSARRAY2, N is incremented by Step
324 and a jump is made back to Step 307.
The reason for having a second answer array that is the negative
(two's complement) of the first array is for checking against loss
or corruption of data. The codes in ANSARRAY1 can be added to yield
some number D. The codes in ANSARRAY2 can be added to yield some
number D*, which should be the complement of D. Therefore, only if
the data is not corrupted D+D*=0. That is, array ANSARRAY2 enables
a simple integrity check of the data before using or printing the
stored data.
Now suppose the gender question 54 "ARE YOU A FEMALE?" is reached
at Step 319. The answer at both Steps 319 and 320 will be "YES" for
a female, leaving the WOMANFLAG set. A male will answer "NO" at
Step 320, causing Step 321 to clear the WOMANFLAG.
With the patient's sex determinable by WOMANFLAG, Step 310 becomes
meaningful. As previously explained, if the second byte of a
Question Structure is 2h, the question is only to be asked of
females. Therefore, suppose Step 310 determines that "NO", the
WOMANFLAG is not set (patient is a male), and Step 311 determines
that the question's second byte indicates that it is for women
only. A branch is made to Step 318, which sets the answer to
"NOTASKD" (not asked). By contrast, if Step 312 does not find a 2
in the second byte of a Question Structure, the question is
displayed to both males and females by Step 312.
We turn next to the backup steps 314, 315, and 316 in FIG. 9. Step
314 determines if the key pressed was the backup key on the control
pad. If it was, Step 315 checks to determine if the current value
of N is 1, the lowest it can be. If it is, N is not decremented,
i.e. there is no backup because we are already at Question 1. But
if N is greater than 1, it is decremented by Step 316, which backs
up the display to the previous question. Logic for the backup mode
to skip over questions that were not asked due to gender, is also
built in.
As explained above, the ASK QUESTIONS, STORE ANSWERS routine ends
when at Step 307 a question is encountered whose question number is
0. A branch is then made to Step 308 to set the VALIDDATA flag,
after which Step 309 executes a Return From Subroutine.
e. Printing A Doctor's Report
Once a set of valid answers has been taken from the patient, from
the main menu (FIG. 3B) the medical staffer can choose to print a
report for the doctor, including suggested tests. The staffer takes
back test selector 20 from the patient, and using printer port 21e
of FIG. 1, connects it to a standard serial printer 42 as shown in
FIG. 2.
To print the report for the doctor, at the main menu (FIG. 3B, FIG.
7, Step 206) the staffer selects command 2. Because Step 207 is
"NO" and Step 215 is "YES", next Step 216 checks to see if the
VALIDDATA flag is set. If it is, there is a valid set of data to
print, and subroutine PRINT DOCREPORT is called at Step 217.
The PRINT DOCREPORT subroutine is shown in more detail in FIG. 10.
The subroutine begins at Step 400 and moves to Step 401, where a
header for the report is printed (see Appendix I) that includes
blanks for handwritten insertion of patient information.
Next, any Follow-Up Questions associated with questions to which
the patient has answered YES are printed. For example, if the
patient has answered "YES", he or she has allergies, the follow-up
question printed will be:
WHAT ARE YOU ALLERGIC TO?
The text of a Follow-Up Question is stored in memory in the
previously mentioned Question Structure after the question to which
it is associated. Also stored in memory is an array called SPCQST
which tells STEP 401 which YES/NO questions have associated
Follow-Up Questions, which answers (YES, NO, NOT SURE) should cause
a Follow-Up Question to be printed, and the address of each
Follow-Up Question.
Next, Step 401 prints a disclaimer (see Appendix I) that includes
information as to the basis for the test recommendations and a
cutoff date beyond which the test guidelines stored in the ROM
memory should not be regarded as valid because they may need
updating.
Step 402 then prints a heading "INDICATED LABORATORY TESTS" Then at
Step 403 an indexing number N is set equal to 1, and the address of
an array TESTINFO, which stores information about each test, is
loaded.
For each test, there is an information entry in TESTINFO according
to the following format:
<TESTNO> The number of the test.
<QUESCOUNT> A number indicating how many Question Numbers are
stored in <QUESADDS>
<QUESADDS> A series of address pointers, each indicating the
address of a question that might give rise to an order for this
test.
<TESTNAME> The name of the test (ASCII string).
The last test entered in TESTINFO is a dummy, the TESTNO of which
is 0 to indicate there are no more tests.
Therefore, at Step 404 the TESTNO of the Nth item in TESTINFO is
checked to see if it is zero. If it is, the program has reached the
final or dummy test and can proceed to Step 405. However, usually
the TESTNO of the Nth item in TESTINFO is not zero, and the program
proceeds to Step 408, where an indexing variable L is set to 1 and
a flag called PRINT is cleared.
Then at Step 409 the variable M is set equal to the QUESCOUNT
associated with the Nth item in TESTINFO. If M =QUESCOUNT=0, there
is no question that could give rise to an order for the Nth test,
and a jump is made to Step 415. Since the PRINT flag was cleared in
Step 408, the result at Step 415 will be a "NO", causing a jump to
Step 417, which increments indexing variable N.
However, usually M=QUESCOUNT >0 because one or more questions
could give rise to an order for the Nth test. At Step 411 the Lth
question address pointer stored in the field <QUESADDS> is
read, and the patient's corresponding answer for this question
pointed to is read from the array ANSARRAY1.
For example, suppose N=1, so that the printing program is computing
whether to set the PRINT flag to print the name of the 1st TEST
under the heading "INDICATED LABORATORY TESTS". Step 409 goes to
item 1 of the array TESTINFO, where it finds the entries:
<TESTNO>
<QUESCOUNT> 13
<QUESADDS> Q01, Q02, Q03, Q04, Q05, Q06, Q07, Q08, Q10, Q11,
Q12, Q54, Q65
<TESTNAME> The name of the test (ASCII string).
Suppose the current value of L=1. Then the first (L=1) question
pointer Q01 is read from the field QUESADDS, and used to access the
information about the indicated question in the QUESTIONS array. In
particular, the indicated Question Number is found to be "1", which
allows the corresponding answer to be read from ANSARRAY1.
If at Step 412, the answer is found not to be "NO" (i.e. found to
be YES or NOT SURE), Step 413 will set the PRINT flag. Later, when
the program reaches Step 415, the set PRINT flag will cause the
test's name to be printed by Step 416.
If at step 412 the answer "NO", there is a jump to Step 414 so the
PRINT flag will not be set. Step 414 checks to see if M=0, which
would indicate that there are no more question address pointers to
be read from field QUESADDS. If M.noteq.0, there is a jump to Step
411 where the index variable L is incremented and the index
variable M is decremented.
Thus, any of the question numbers associated with a test can, for a
YES or NOT SURE answer, cause the PRINT flag to be set at Step 413.
When Step 414 finds that M=0, the PRINT flag is checked by Step
415, and if it is set, the TESTNAME is printed at Step 416. Then
the program proceeds to Step 417 where the indexing integer N is
incremented to proceed to the next test.
If none of the answers to the questions associated with the Nth
Test has set the PRINT flag, at Step 415 the answer is "NO", and
there is a jump to Step 417 where N is incremented to the next test
in TESTINFO.
As mentioned above, as N is incremented, eventually the final or
dummy test whose TESTNUMBER is "0" is reached. Then the result of
Step 404 is a YES, and Step 405 prints a heading "PATIENT REPORTS
RECENTLY HAVING THE FOLLOWING TESTS:". To determine what comments
should be printed about past tests, reference is then made to the
array STATEMENTS. This array gives pointers to any YES Comment
String, NO Comment String, or NOT SURE Comment String which follows
a Lab Test Question. The patient's stored answers determine which
of these three comment strings is printed.
For example, question 67 asks if the patient has had a blood test
in the last six months. The YES Comment String to be printed at
Step 406 is "PATIENT HAS HAD A BLOOD TEST IN THE LAST 6 MONTHS.",
and the NO and NOT SURE Comment Strings are "PATIENT MAY NOT HAVE
HAD A BLOOD TEST IN THE LAST 6 MONTHS."
After these lab test comments are printed at the end of the
doctor's report, Step 406A prints Comment Strings about the patient
that will be helpful to the doctor's selection of tests. For
example, if the patient answered "YES" that he or she wears
dentures, a YES Comment String "PATIENT WEARS DENTURES" will be
printed. A table of which questions have a printable associated YES
Comment String or NO Comment String is stored in an array
STATEMENTS.
After these special comments are printed, Step 407 executes a
Return From Subroutine
f. Printing Questions & Answers
If a set of valid answers has been taken from the patient, from the
main menu (FIG. 3B) the medical staffer can also choose to print
out the questions together with the patient's answers, including
follow-up questions with blanks for handwritten answers. As in the
case of the Doctor's Report, test selector 20 is connected to a
standard serial printer 42 as shown in FIG. 2 via printer port
21e.
To print the questions and answers, at the main menu (FIG. 3B, FIG.
7, Step 206) the staffer selects command 3. Because Steps 207 and
215 are "NO" and Step 220 is "YES", next Step 221 checks to see if
the VALIDDATA flag is set. If it is, there is a valid set of data
to print, and the subroutine PRINT Q&A RESPONSES is called at
Step 222.
The PRINT Q&A RESPONSES subroutine is shown in more detail in
FIG. 11. The subroutine begins at Step 500 and moves to Step 501,
where a header for the report is printed (see Appendix II). A line
is printed that instructs the patient, "PLEASE REVIEW YOUR
ANSWERS". An indexing variable C is set equal to 1.
Next, any Follow-Up Questions associated with questions to which
the patient has answered YES ar printed with blanks to be completed
by the patient. This is done in a manner similar to that described
for Step 401 of the subroutine PRINT DOCREPORT of FIG. 10. The
Follow-Up Question is stored in memory in the Question Structure
after the question to which it is associated. The array called
SPCQST tells STEP 502 which YES/NO questions have associated
Follow-Up Questions, which answers (YES, NO, NOT SURE) should cause
a Follow-Up Question to be printed, and the address of each
Follow-Up Question.
The questions are divided into groups separated by titles printed
at Step 503. The title printed at Step 503 depends on the current
value of the variable C: 1=LAB TESTS, 2=ANESTHESIA, 3=GENERAL
HEALTH. For each value of C (1, 2, 3), Step 504 calls the
subroutine SORT AND PRINT QUESTIONS AND ANSWERS of FIG. 12 to print
the questions and answers having the Question Class which
corresponds to the current title Within a title, the order of
printing is questions answered "YES" questions answered "NOT SURE",
and questions answered "NO". For example, when C=1, calling the
subroutine of FIG. 12 will only cause the questions and answers
related to LAB TESTS to be sorted out and printed in this
order.
Then at Step 505, the variable C is incremented so, questions and
answers under the next title can be printed Assuming that there are
just three titles, a check is made at Step 506 to see if C=4. If it
does not, there is a jump back to Step 503 for the next title. But
if C=4 at Step 507, there are no more titles and a signature line
for the patient is printed under the words "THE ABOVE ANSWERS ARE
CORRECT AS TYPED". After the signature line is printed, there is a
Return From Subroutine at Step 508.
The SORT AND PRINT QUESTIONS AND ANSWERS subroutine is shown in
more detail in FIG. 12. The routine begins at Step 600 with some
given value of C (1, 2, or 3) from the calling subroutine of FIG.
11. At Step 601 the respective addresses of the QUESTIONS ARRAY and
first ANSWER ARRAY are noted. At Step 602 an indexing variable
ANSTYPE is initially set to 1.
The variable ANSTYPE has the following meanings 1=YES answer, 2=NOT
SURE answer, 3=NO answer, 4=NOTASKD (end of printed answers).
Therefore, at Step 603 a check is made to see if the indexing
variable ANSTYPE equals four. If it does, there is a Return From
Subroutine at Step 604.
However, initially ANSTYPE is one because of Step 602, and the
program proceeds to Step 605 where an indexing integer N is set to
1. Then at Step 606, the first byte of the Nth Question Structure
stored in the questions array QARRAY is read. If it equals zero,
the dummy Question Structure has been reached that indicates there
are no more questions to process.
However, usually the first byte is not zero, in which case Step 608
compares the Question Class of the Nth Question Structure with the
value of C input to the subroutine. If the Question Class does not
match C, a jump is made to Step 612, where N is incremented and a
jump made back to Step 606 to check the first byte of the next
Question Structure.
When the Question Class of the Nth Question Structure matches the
value of C at Step 608, the corresponding answer is obtained from
answer array ANSARRAY1 by Step 609. If the answer matches the
current value of ANSTYPE, the Question and its corresponding Answer
are printed at Step 611. Otherwise, the Question and Answer are
skipped by jumping to Step 612, where the variable N is incremented
Then there is a return to Step 606 to read the first byte of the
next question structure.
For each value of ANSTYPE, eventually N is incremented at Step 612
until the dummy Question Structure is reached, causing a "YES" at
Step 606. Then Step 607 increments ANSTYPE to the next type of
answer. Eventually, Step 607 causes ANSTYPE to equal four, which is
detected by Step 603 to cause a Return From Subroutine at Step 604
as mentioned above.
Thus, for a given category of question C, the subroutine of FIG. 12
first prints all the questions answered "YES", then all those
answered "NOT SURE", and then all those answered "NO". Within a
category, the answer given to a question determines its order in
the printout.
In the first embodiment of the invention so far described, the
subroutine ASK QUESTIONS, STORE ANSWERS of FIG. 9 processes each
question in sequence (FIG. 13C), but if the WOMANFLAG is CLEAR
certain questions only for females are not displayed (FIG. 9, Step
311) and automatically answered "NOTASKD" (not asked) by Step 318
As shown in FIG. 13A, the flag check FCh causes question Q.sub.i to
be skipped when the WOMANFLAG is CLEAR and instead processing
proceeds to question Q.sub.i+1.
For a male patient, if the program has to be backed up from
question Q.sub.i+1, logic is built in so that backup key 37 skips
question Q.sub.i and returns to previous question Q.sub.i-1, here
assumed to be a general question for both men and women. Thus, this
simple automatic skipping of certain questions irrelevant to the
particular patient does not greatly complicate use of backup key
37.
In the subroutine PRINT DOCREPORT, which prints a report to the
doctor, questions whose answer is "NO" or "NOTASKD" do not cause
the associated test to be printed (Step 412). The subroutine SORT
AND PRINT QUESTIONS AND ANSWERS of FIG. 12 treats questions having
the answer "NOTASKD" as a forth type whose printing is skipped by
the action of Step 603.
A second embodiment of the invention allows for more general
branching to further questions in accordance with the patient's
answers and provides a means for storing the return path needed to
support backup key 37. A source code listing of the control program
for the second embodiment is attached as Appendix IV.
As shown in FIG. 13D, in the second embodiment the next step of the
control program after displaying question Q.sub.i depends on
whether the answer to question Q.sub.i is YES (Y) or NO (N). In the
general case, as shown in FIG. 13B, we must also allow for the
alternative paths to converge at certain questions, such as
Q.sub.13 and Q.sub.18. To move backwards to previous questions
along the correct alternative paths requires special support for
backup key 37.
As shown even more generally in FIG. 13E, each question Q.sub.i can
be followed by a branch to one of three different paths Y, N, NS,
corresponding to YES, NO, and NOT SURE. FIG. 13F shows the
tree-like structure of the possible paths of the program when the
next question to be asked depends on whether the answer is YES, NO,
or NOT SURE.
To enable such branching, the previously mentioned Question
Structure stored for each question in the QUESTIONS array is
augmented as follows:
<Question Number><Assoc Flag><Question Class>
<Text String>
<Branchflag><Next/Yes Question Pointer>
[<No Question Pointer>]
The additional parts of the Question Structure which enable
branching are a BRANCHFLAG, a NEXT/YES QUESTION POINTER and a NO
QUESTION POINTER. If a particular question does not need branching,
such as question Q.sub.i of FIG. 13C, the BRANCHFLAG is CLEAR, the
NEXT/YES QUESTION POINTER is used as a pointer to the next question
Q.sub.i+1, and the NO QUESTION POINTER is not: present.
A question leading to a YES or NO alternative (see FIG. 13D) has
its BRANCHFLAG SET. The NEXT/YES QUESTION POINTER points to the
next question that should follow a "YES", and the No Pointer points
to the next question that should follow a "NO". For purposes of
branching, the test selector can be designed to always treat an
answer of "NOT SURE" as either a "YES" or a "NO". Alternatively,
the test selector's Question Structure can be further augmented to
add a separate pointer [<Not Sure>] for a third alternative
as shown in FIG. 13E.
For example, to enable branching which treats an answer of "NOT
SURE" like a "YES", FIG. 14 shows a subroutine ASK QUESTIONS, STORE
ANSWERS V2 to be substituted for the first embodiment's ASK
QUESTIONS, STORE ANSWERS subroutine of FIG. 9. Beginning at Step
700, the VALIDDATA flag is cleared at Step 701 and a portion of RAM
memory 142 (FIG. 5) is initialized as a first-in-last-out stack
called PATHSTACK for question address pointers Then the address of
the array "HOWTOUSE" is loaded at Step 703, and an index integer N
set initially to 1.
Step 704 tests the first byte of Instruction N for 0h. Since the
Instruction screens have some other hexadecimal number in the first
byte, a jump is made to Step 707, which causes Instruction screen N
to be displayed and N incremented. Then Step 708 causes a pause
until the next answer keypad input, after which there is a jump to
Step 704 to check the first byte of the next Instruction Screen.
Finally, a first byte of 0h in the last (dummy) screen is detected,
indicating that all the Instruction Screens have appeared to the
patient on display 22. The program proceeds to Step 705 where each
element of the two answer arrays ANSARRAY1 and ANSARRAY2 is
initialized to "NOTASKD" (not asked).
The address of the QUESTIONS array is loaded at Step 706, and the
first question pointer used to obtain the address of the Question
Structure for the first question. The first byte of this Question
Structure is examined at Step 709 to see if it is 0. Usually it is
not, so the program proceeds to Step 710 which clears the screen
and displays the text of the question pointed to. Then Step 711
waits for an answer to be input at the patient's keyboard.
Assuming at Step 712 that the backup key # has not been pressed,
Step 713 saves the patient's YES, NO, or NOT SURE answer as
distinguishable binary codes in an corresponding entry of an answer
array ANSARRAY1. Then Step 718 determines the two's complement of
the answer code, and Step 719 saves this in a second answer array
ANSARRAY2.
If instead Step 712 finds that the backup key on the control pad
was pressed, Step 714 determines if the current question pointer is
that pointing to the first question. If it is, there is no backup
because we are already at Question 1. But if Step 714 determines
that the question currently pointed to is greater than 1, Step 715
pops the pointer for the previously asked question off the
PATHSTACK. Then a jump is made back to Step 709 to process the
previously asked question.
After Step 719 has saved the two's complement of an answer in
ANSARRAY2, Step 720 pushes the current question pointer onto the
PATHSTACK. If Step 721 finds that the BRANCHFLAG is SET, Step 722
determines if the patient's answer is NO. If it is, Step 723 uses
the NO QUESTION POINTER of the current question for the address of
the next question to be asked, and a branch is made back to Step
709.
If instead the patient's answer is "YES" or "NOT SURE", Step 724
uses the NEXT/YES QUESTION POINTER of the current question for the
address of the next question, followed by a branch back to Step
709.
If Step 721 finds that the BRANCHFLAG is CLEAR, the answer to the
current question does not cause branching into alternate paths.
Step 724 uses the NEXT/YES QUESTION POINTER of the current question
for the address of the next question to be asked, and there is a
branch back to Step 709.
The ASK QUESTIONS, STORE ANSWERS V2 routine ends when at Step 709 a
question is encountered whose question number is 0. A branch is
then made to Step 716 to set the VALIDDATA flag, after which Step
717 executes a Return From Subroutine.
In this manner, the PATHSTACK, BRANCHFLAG, NEXT/YES QUESTION
POINTER, and NO QUESTION POINTER of the second embodiment enable
more general branching to further questions in accordance with the
patient's answers, without sacrificing the function of backup key
37. This enables the questions asked to be highly relevant and
detailed with respect to the patient's age, sex, history and
condition, and facilitates the asking of follow-up questions. Since
the answer arrays are initialized to "NOTASKED", it is easy for the
subroutines DOCREPORT and PRINTQ&A to ignore unasked
questions.
The invention provides a compact, portable automatic test selector
for taking patient histories which is easily used, even by
bed-ridden patients, and especially adapted for the selection of
medical and pre-operative tests. The test selector is easily
connected to a printer to print out a report to the doctor of
recommended medical and/or pre-operative tests and a sorted list of
the questions and the patient's answers. It can also be attached to
a suitable computerized work station. In addition, there is
provision for the patient to review and supplement the answers.
While the principles of the invention have been described above in
connection with specific apparatus and applications, it is to be
understood that this description is intended only by way of example
and not as a limitation on the scope of the invention. Therefore,
the following claims are to be construed to cover all equivalent
structures.
LIST OF APPENDICES
I. Appendix I--Report to Doctor
II. Appendix II--Printout of Questions and Answers
III. Appendix III--Source Code for Embodiment 1
IV. Appendix IV--Source Code for Embodiment 2
* * * * *